Sr. Quality Control Analyst at Lenexa

Job Description

Provides advanced technical expertise in all areas of laboratory testing, contamination control, and problem resolution. Plan/execute testing and process investigations including preparation of protocols, summary reports, and data summaries. Serves as intermediary on organizational efforts to meet customer and/or regulatory requirements such as compendial method revisions or CFR changes. Utilizes extensive and diverse experience with a hands-on approach to streamline laboratory operations and resolve problem areas.

1.Oversees and performs raw material and finished product sampling, testing, peer review, and disposition, assuring timely completion and GMP testing documentation.2.Assures timely execution of stability testing and raw material qualification testing with appropriate documentation and failure resolution.3.Participates in Raw Material Review Board where raw material quality discussion and decisions are made.4.Participates as Subject Matter Expert on project teams and investigations.5.Oversees test method and other QC SOP generation in support of Microbiological testing and other related laboratory activities.6.Ensure test methods comply with appropriate compendia including but not limited to USP, EP, ACS, etc.7.Ensure test methods are validated or verified as appropriate to the method.8.Ensures Microbiology group Analysts are trained consistent with Corporate policy including complete and accurate documentation and content addressing: job skills, quality awareness, cGMPs, ISO, Job Skills, and training in compliance related areas.9.Participates in establishment of QC policies in conjunction with QC Supervisor.10.Participates as lead for Microbiology / raw material test methods and data during customer audits. Facilitates closure of customer and supplier audit observations.11.Leads and/or participates in Out-of-Specification and other problem solving activities assuring timely resolution of issues and ensuring corrective actions have been taken and documented.12.Lead continuous improvement efforts as agreed with Supervisor / Manager.13.Performs other activities as may be directed from time to time.

Job Requirements

Required:1.Bachelors degree in science (or equivalent) with three or more years experience in a Microbiology laboratory in a regulated industry with familiarity with GMPs, GLPs and/or related FDA requirements or equivalent combination of education and experience.2.Good written and oral communications skills3.Demonstrated decision making skills4.Team player capable of leadership in high pressure situationsPreferred:1.Bachelors degree in Biology (or equivalent) with five or more years experience in a Microbiology laboratory in a regulated industry with familiarity with GMPs, GLPs and/or related FDA requirements or equivalent combination of education and experience.2.Demonstrated ability to interact with others using written and oral communication skills3.Demonstrated knowledge of GMP/GLP laboratory procedures.4.Demonstrated ability to lead in high pressure situations
Country: USA, State: Kansas, City: Lenexa, Company: Sigma-Aldrich.